A version of this article first appeared in CNBC's Healthy Returns newsletter, bringing the latest healthcare news directly to your inbox. Subscribe here to receive future editions.
The Food and Drug Administration may add its strongest safety warning to Covid shots, marking another major change in vaccine oversight.
It could also expand on a series of actions by Trump administration health officials that some health experts say could undermine confidence in the shots, which have saved millions of lives around the world since they were introduced. Adoption of these vaccines is already plummeting: The National Foundation for Infectious Diseases, citing IQVIA data, said last week that there has been a 27% decline in Covid vaccinations in retail pharmacies since 2024.
This is what we know so far.
The FDA is preparing to add what is known as a “black box” warning to Covid vaccines by the end of the year, CNN first reported on Friday.
That plan, which is not yet finalized, is being pushed by Dr. Vinay Prasad, the FDA's chief medical and scientific officer and director of the agency's Center for Biologics Evaluation and Research, CNN reported.
That type of label is not used lightly. It appears at the top of a drug's prescribing information and is designed to warn of risks such as death or serious injury that must be weighed against the benefits of a product.
For example, boxed warnings on opioids warn of risks of addiction, overdose, and death.
But there are still many unanswered questions here.
First, the Department of Health and Human Services did not confirm any of the plans today.
In a statement to CNBC, HHS spokesperson Andrew Nixon said, “Unless the FDA announces it, any statement about what it will do is pure speculation.”
We also do not know if this warning will apply to the three Covid vaccines.
HHS Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic, and some of his appointees have previously targeted Covid mRNA shots from Pfizer and Moderna.
But Novavax also offers a protein-based Covid vaccine.
It is also unclear whether this warning will only apply to certain age groups and what problem the label will point out.
Prasad, in an internal FDA memo last month, attempted to link 10 child deaths to Covid vaccines, without providing any evidence. It also highlighted myocarditis, an extremely rare side effect after administration of Pfizer and Moderna mRNA injections. Cases of this side effect were detected with early use of the injections, when the first and second doses were recommended to be administered with an interval of up to three weeks. The side effect was also predominantly observed in boys and men.
But health authorities around the world, including the Centers for Disease Control and Prevention, have emphasized that the benefits of vaccination in preventing severe Covid and even myocarditis from the infection itself far outweigh the small risk of side effects posed by the shot. Myocarditis cases have also decreased dramatically in recent years.
So what are vaccine manufacturers responding today?
Pfizer pointed to previous statements supporting the safety and effectiveness of its Covid vaccine.
The vaccine “has consistently provided strong protection against severe and symptomatic COVID-19 disease across multiple variants and subvariants, saving more than 14 million lives worldwide in the first year after approval, and many more since,” Pfizer said.
Moderna pointed to a statement it issued in September, which says the safety of its Covid vaccine is “rigorously monitored” by the company, the FDA and regulators in more than 90 countries. With more than one billion doses distributed worldwide, those systems “have not reported any new or undisclosed safety concerns in children or pregnant women,” according to the statement.
We'll be watching to see if the FDA adds these warnings to the shots, so stay tuned for our coverage.
Feel free to send any tips, suggestions, story ideas and facts to Annika at a new email: [email protected].
